Endotracheal tubes

ABSTRACT

Disposable endotrached tubes are provided, such tubes having an adapter portion integral with a body portion through a juncture, with a lumen of substantial constant diameter extending throughout the body portion and juncture, the lumen opening into the adapter through a region of generally nonturbulent flow. In one embodiment, the juncture portion is corrugated to provide a flexible connection at any desired angle between adapter and body portion.

9 United StatesPatent A 72] Inventor Roland L. Tindel 846 Oak Valley,Houston, Tex. 77024 [21 Appl. No. 888,145 1 [22] Filed Dec. 29, 1969[45] Patented Aug. 17, 1971.

Continuation of application Ser. No. 624,455, Mar. 20, 1967, nowabandoned.

[54] ENDOTRACHEAL TUBES 2 Claims, 7 Drawing Figs.

52 us. c1 128/351 [56] References Cited UNITED STATES PATENTS 2,638,0965/1953 Waldhaus 128/348 3,035,691 5/1962 Rasmussen et al 206/6323,112,031 11/1963 Stewart 206/632 3,297,027 '1/1967 Rusch 128/14553,363,629 H1968, Kuhn 128/351 3,388,705 6/1968 Grosshandler. 128/3513,395,711 8/1968 Plzak..... 128/351 4 FOREIGN PATENTS 666,090 7/1963Canada 128/350 19,803 1904 GreatBritain 128/349 OTHER REFERENCES LancetFeb. 27, I965 Vol. H65 7383 p. 468, l28-35l Primary Examiner- Dalton L.Truluck AttorneyArnold, Roylance, Kruger & Durkee ABSTRACT: Disposableendotrached tubes are provided, such tubes having an adapter portionintegral with a body portion through a juncture, with a lumen ofsubstantial constant diameter extending throughout the body portion andjuncture, the lumen opening into the adapter through a region ofgenerally nonturbulent flow. In one embodiment, the juncture portion iscorrugated to provide a flexible connection at any desired angle betweenadapter and body portion.-

ENDOTRACHEAL TUBES This, application is a continuation "of applicationSer. No. 624,455 filed Mar. 20, 1967, now abandoned.

Thisinvention relates to tubes adapted for insertion into the trachea ofa patient, for the purpose of administering anesthetics or facilitatingbreathing of the patient, for example, during surgery. Morespecifically, the invention relates to such tubes which are constructedso that they are disposable after use, eliminating sanitation problemswhich exist with the prior art'tubes of this nature, and which providegreater safety and adaptability than do the prior'art tubes.

The trachea is the tube which connects the larynx and'the bronchi in thehuman body. The inside of the trachea and bronchi contain secretoryglands, and their mucousal layer is lined with ciliated cells whichcontinuously carry mucous and inspired material from the lungs throughthe larynx, where it may be coughed up The presence of broncho-pulmonarysecretions can produce serious problems when the patient is underanesthetics. I

Tubes for insertion into the trachea, commonly referred to asendotracheal tubes (or sometimes intratracheal tubes) are commonly usedby the anesthesiologist in the application to the patient of aninhalation anesthetic. Such tubes are further useful in facilitatingbreathing of the patient while he is under anesthesia by keeping theairway open. 7

Prior art endotracheal tubes have been constructed generally of rubberbody portions and metal fittings such as adapters and connectors. Somesuch tubes have been constructed'of plastic instead of rubber bodyportions. But in either case, the tubes are relatively expensive andconsequently must be reused many times by the hospital to justify theexpense of the tubes. There are'many problems inherent in thisprocedure, the foremost among which are the lack of proper sterilizationof reused tubes and the wearing out of the tubes after continued usewith the result that a defective tube might be inadvertently used onsome occasions. A primary consideration to all hospital functions, andespecially surgical procedures, is cleanliness, and indeed,sterilization. When an endotracheal tube is used on the patient, it isof course exposed throughout its length to the mucous from the trachea,mucous which carries dangerous organisms in many patients, oftenincluding infectious diseases such as tuberculosis.

When an endotracheal tube has been used, it is the customary procedureto then clean it thoroughly, But many hospitals today are badlyunderstaffed, and it is inevitable that sometimes tubes will be reusedbefore they have been adequately cleaned, indeed sometimes before theyhave been cleaned at all. It is emphasized that the cleaning andsterilization process for such rubber and plastic tubes is verydifficult,

and it is further difficult to ascertain exactly when sufficient vcleaning has been accomplished. Although reported instances ofcommunication of infectious disease in this manner may be relativelyrare, it is very serious when it does happen. And with the increasinguse of endotracheal tubes, whereby there are many thousands of suchtubes used in just the United States each day, a great many patients areexposed to infections and are indeed contaminated in this manner.

Many other problems are inherent in the prior art endotracheal tubes.One such problem is that with the rubber tubes and-some of the plastictubes of the prior art, bending of the tube has at times causedconstriction of the lumen or passageway to completely terminate flowthrough the tube. When this occurs, there is of course the possibilitythat the ox ygen supply to the patient will be interrupted causing thepatient to die of asphyxia. This difficulty is often due to weakness ofthe tube from continued use, and-is eliminated by use of the presentinvention. p

A further problem concerns the frictional resistance offered by the tubein the trachea. Because many of the prior art tubes aredifficulttoreadily move'through the trachea because of the frictionofthe side of the tube against the interior wall of the trachea, watersoluble jelly is customarily used on'the ex-' vention;

terior of the tubes to insure lubricity. But the water soluble may alsoon occasion collect inside the lumen, thus partially or completelyoccluding up the tube. Partial occlusion is extremely dangerous in thatit may cause gradual asphyxia, often resulting in irreparable celldamage to the patient before the occlusion'is noticed by the attendant.

Yet a further problem with the prior art devices is that in thesedevices an area of turbulence generally exists at the point where thebody of the tube is joined to the separate connector or adapter. It willbe recognized that turbulence of flow is most undesirable in thesecontexts of use wherein it is essential that the patient receive thecorrect dosages of anesthetic in the correctproportion of oxygen, forexample, and that he receive it in a continuous and uniform manner. Thisarea of turbulence is eliminated by use of the present invention.

Another problem with prior art endotracheal tubes which are constructedwith separate joining fittings, is that on some occasions hospitalpersonnel have insufficiently joined the fitting to the tube, resultingin separation of the tube from the fitting during use, thus shutting offthe patients supply of oxygen, etc. Here again, this occurrence isrelatively rare, but it is a serious thing when it does happen, and thishazard is eliminated by use to the present invention.

Still another difficulty with the prior art tubes has been with theinflatable cuffs which are commonly used on such tubes to seal theannulus between endotracheal tube and trachea upon inflation. Thesecuffs are made of rather thin rubber or plastic (much like a balloon),and this material tends to wear out rather quickly. The result is thatthe cuffs are often damaged-sometimes unknowingly-and this damageresults in an inadequate seal when the tube is used again. Thisdeficiency is also eliminated by use of the present invention.

Among the other more important disadvantages existing in the prior art,are that prior art tubes are generally nonadaptable to varying uses andconstructions, and are relatively expensive to manufacture. Thesedisadvantages, which strike at the heart of. practical application ofany product, are eliminated by use of the instant invention.

In order that the present invention may be understood in detail, severalspecific embodiments thereof are illustrated in the accompanyingdrawings, wherein:

FIG. 1 is a pictorial view of one embodiment of an endotracheal tubeconstructed in accordance with this invention;

FIG. 2 is apictorial view of an endotracheal tube constructed inaccordance with another embodiment of this in- FIG. 3 is a pictorialview of an endotracheal tube constructed in accordance with yet anotherembodiment of this invention;

H6. 4- is a pictorial view of an endotracheal tube constructed inaccordance with still another embodiment of this invention;

FIG. 5 is a pictorial view of the adapter end of endotracheal tubesconsti'ucted in accordance with embodiments of this invention,-andspecifically illustrates the adapter end of the FIG. 6 embodiment;

FIG. 6 is a longitudinal cross-sectional view of an endotracheal tubeconstructed in accordance with one embodiment of the invention; and, 1

FIG. 7 is a pictorial view of an endotracheal tube of this invention ina disposable package, comprising a novel disposable article of commercein accordance with this invention.

Referring'now to the drawings in greater detail, there is seen in FIG; 1a unitary endotracheal tube 10 constructed in accordance with oneembodiment of the invention. This unitary tube l0'is constructed of amedically approved synthetic polymeric material such as nontoxicpolyvinyl chloride or polypropylene. The tube 10 comprises a relativelylong body portion 11 which is preferably gently curved so as to conformto the patient's anatomy, in a manner such as'illustratedin FIG. 1, anda neck l2 terminating in an adapter 13 or other suitable fitting whichis located on the side of neck 12 opposite the body portion II.- Thecurve of the tube is such that it fits firmly in the trachea withoutforcing any part of the trachea out of positiom'lhe adapter, connector,or other fitting is such that it will conveniently fit onto a piece ofauxiliary equipment,v for example the outlet or nozzle of a source ofoxygen or anesthetic. It is desirably tapered gently from a firstdiameter adjacent neck 12 to a slightly smaller diameter adjacent theopening 15.

A-pass'ageway or lumen 17 extends through the tube,-opening at theadapter in an opening 15 and at the opposite end in a beveled opening 16which is of a size significantly larger that the diameter of lumen 17.Lumen 17 is free of constriction, and the diameter of the lumen isconstant throughout body portion 11. The bevel at opening 16 in thisinstance is about 45, and this bevel angle has been found to be veryimportant body portion, is connected to the body portion 51 by means ofto proper operation of the tube in many instances, in order that theproper fit at the lower end of the trachea is assured. A bevel of about30 has been found desirable for certain nasal tubes.

An inflatable cuff 18 is positioned around the tube near the lower endthereof. The purpose of this cuff is to assure, upon inflation thereof,a seal between trachea and outer wall of the tube 10, sothat unwantedfluid may not be passed up the annulus between trachea and tube wall,and that all flow must be through the lumen 17 of the endotracheal tube.The cuff 18 is constructed, in accordance with this invention, of a thinlayer of plastic material which circumscribes the tube 10. When the cuff18 isin its deflated position, it assumes the samediameter,approximately, as the remainder of the tube 10. In this manner, the tube10 has no enlarged portion for presenting difficulty asthe tube isintroduced into the trachea. When the cuff 18 is inflated, on the otherhand, it presents a balloonlike surface which is greatly larger indiameter than the mean diameter of the tube 10. I

Inflation ofthe cuff 18 is accomplished by means of an inflatingpassageway 19 which may be conveniently connected to any suitable sourceof air or other fluid for inflation of the cuff. An indicating bulb 20is conveniently placed at an intermediate positionalong the inflatingpassageway 19.

It is noted that in the FIG. 1 embodiment, the neck 12 makes an angle ofabout 90 with the body 11 of the'tube, at the juncture 14. This is aparticular type of tube which has been found to be of special utility inmany circumstances.

wherein endotracheal tubes are employed.

FIG. 2 illustrates an endotracheal tube 30 in accordance with anotherembodiment of the invention. The tube 30 comprises generally a bodyportion 31, which is joined at juncture 34 to a neck 32 which is, inturn, connected to a suitable fitting such as. the adapter 33. Lumen orpassageway 37 extends through'the tube 30, communicating to the exteriorof the tube through opening 35 in the adapter and beveled opening 36 inthe end of the body 31 of the tube. Here again, the desired angle ofbevel is found to be about 45. Y

The tube 30 also includes an inflatable cuff 38, which is inflated bymeans of an inflating passageway 39 in which is located an indicatingbulb 40. The inflating passageway may be disposed a certain distancewithin the wall of the tube 30, or alternatively it may protrude on theexterior of the wall of the tube. Of course, if it protrudes, it isunderstood that this will present an enlargement of the tube diameterwhich may in some instances present difficulty in passing the tube intothe trachea.

In the FIG. Zembbdiment, the neck 32 is joined to the body portion 31 ofthe tube at an angle of about 45, this arrangement having been found togive good results in many contexts of use for endotracheal tubes.Otherwise, it is noted that the FIG. 2 embodiment is similar to theembodiment ofFlG. I.

It is further noted at this point that the reverse angle may be providedfor either the FIG. 1 or FIG. 2 embodiment'iThat is,

for some uses, the reverse 90, or reverse 45, angleofjunction of theneck and body may be desirable. Y

a corrugated juncture 54. This juncture 54 is constructed of the samematerial as is the remainder of the tube 50, and being corrugated theupper portion of the tube is freely bent away from the body of the tubein any direction without constricting the lumen 57 which passes throughthe tube. That is, the neck 52 may join the body 51 at any desiredangle. This construction has been found particularly useful in thoseoperations in which the patient must assume an abnormal position, suchas brain surgery.

The lumen 57 of tube 50 opens at one end through the opening 55 in theadapter and at the other end of the tube through the opening 56 in thebody of the tube. As in the FIGS. 1 and 2 embodiments, a cuff 58 isincluded around the lower part of the body of the tube, this cuff beinginflatable by means of an inflating passageway 59 in which may belocated an indicator bulb 60. v 7

An endotracheal tube suitable for use in an infant is illustrated inFIG. 4. This tube 70 comprises a body portion 71 which has across-sectional area generally smaller than the cross-sectional area ofthe tubes illustrated in the foregoing embodiments. For example, whereasthe tubes in the FIGS. 13 embodiments may generally be constructed witha lumen diameter of between 2% (without cuff) or 3% (with'cuff) min. to10mm., the lumen diameter in the FIG. 4 embodiment will generally be onthe order of 25 mm.

The ball-shaped adapter 73 is convenient for use with certain medicalequipment and is suitable for connection into a T- or Y- connector. Theadapter 73 is joined to body 71 through a neck 72 and juncture 74, whichin this embodiment has a curvature of 90. Lumen 77 runs through thetube, exiting at the end opposite adapter 73 through the beveled opening76.

In FIG.'5 a particularly advantageous feature of the invention isillustrated. In prior art tubes where separateadapters must necessarilybe joined to endotracheal tube bodies, there has existed a turbulence offlow at the point where the two meet. This turbulence is caused by theirregularity in lumen diameter between the tube (small diameter) and theadapter (large diameter). Such turbulence is undesirable and, moreover,can be quite critical.

The present invention as illustrated in the FIG. 5 embodiment eliminatesthis turbulence problem by providing for a smooth'and gradualtransformation from the smaller diameter tube body into the largerdiameter adapter. This is clear from reference to FIG. 5, wherein it isseen that the inner wall 94 of the endotracheal tube curves on a gradualcurve through the region 95 of adapter 83, between the opening 85 andthe neck 82.

In FIG. 6 is seen a cross section of a tube constructed in accordancewith any of the embodiments of FIGS. 1-3. Here is seen the tube 80comprising generally body portion 81, neck 82 and adapter 83. Lumen 87passes through the tube opening through the adapter at opening andthrough the opposite end of the tube at beveled opening 86. A cuff ofexpansible material 88 is adapted to be inflated through an inflatingpassageway 89 in which is included an indicating bulb 90. In thisembodiment it can readily be seen that the passageway from the tube 89enters the tube wall 93 on one side of the cufi, continues in theinterior of the wall 93, and terminates at the opposite end'of the cuff88. In this manner, it is seen how introduction ofa fluid such as airunder pressure will inflate the cuff 88 without inflating thesurrounding areas of the tube 80. In this embodiment it is also seen howthe thickness of wall 93 varies throughout the length of the tube, thewall thickness being greater in the body portion of the tube. Thenonuniform bulence of flow, is also noted. The lumen 87, however, isseen i to be of uniform diameter throughout the length of the tube. It

' single piece.

FIG. 7 illustrates still another advantageous embodiment of the presentinvention. Here is seen a'tube 100 constructed in accordance with any ofthe foregoing embodiments, in a disposable package 101 which mayconveniently be of generally rectangular configuration as shown with atransparent top 102 of clear plastic material or the like. In thismanner the surgeon or nurse may clearly see what type and style of tubeis in the container, and each tube may be separately packaged in its owndisposable container. The economy of this procedure is such that thetubes themselves may be disposed after use in one patient.

From the foregoing embodiments it is seen that endotracheal tubes havebeen provided which are unitary in construction, are feasible fordisposing after one use, are much safer than the prior art tubes, andpromote nonturbulent flow therethrough. These advantages are significantand of great benefit to medical science.

While the invention has been explained in terms of a number ofparticularly advantageous embodiments, it will be apparent to thoseskilled in the art that numerous changes and modifications may be madein the structure of the various embodiments without departing from thescope of the invention, which is defined by the following claims.

What I claim is:

l. A unitary disposable endotracheal tube for insertion through themouth or nose of a patient into the trachea during a surgical operationor the like, comprising:

a gently curved body portion having a substantially constant outsidediameter of a size such that said portion is adapted to fit in thetrachea of the patient;

an adapter portion at the end of said tube opposite said body portion,said adapter being suitable for attaching said tube to surgicalequipment, and said adapter having a maximum inside diameterapproximately equal to said outer diameter ofsaid body portion;

a juncture portion joining said body portion with said adapter portion,said juncture portion being of a length greater than said adapterportion but less than said body portion, and said juncture portiongently curving in such a manner that the end of said juncture portionadjacent said body portion is axially aligned therewith while the end ofsaid juncture portion adjacent said adapter is axially aligned with saidadapter;

a lumen of generally uniform diameter extending throughout said junctureand body portions of said tube, opening through a gently curved regionof nonturbulent flow into said adapter at one end, and through a beveledopening in said body portion at the end of said tube opposite saidadapter, the diameter of said lumen throughout said juncture and saidbody portion being not greatly smaller than said maximum diameter ofsaid adapter;

said body portion, said juncture and said adapter being constructed asan integral unit of a suitable synthetic polymeric material.

2. A unitary disposable endotracheal tube for insertion through themouth or nose of a patient into the trachea during a surgical operationof the like, comprising:

a gently curved body portion having a substantially constant outsidediameter of a size such that said portion is adapted to fit in thetrachea of the patient; an adapter portion at the end of said tubeopposite said body portion, said adapter being suitable for attachingsaid tube to surgical equipment, and said adapter having a maximuminside diameter approximately equal to said diameter of said bodyportion;

a juncture portion joining said body portion with said adapter portion,said juncture portion being of a length greater than said adapterportion but less than said body ortion;

said juncture portion being corrugated to provide a flexible connectionat any desired angle between said adapter and said body portion, theoutside diameter of said corrugated portion being not significantlygreater than the outside diameter of either said body portion or saidadapter,

a lumen of generally uniform diameter extending throughout said junctureand body portions of said tube, opening through a gently curved regionof nonturbulent flow into said adapter at one end, and through a beveledopening in said body portion at the end of said tube opposite saidadapter, the diameter of said lumen throughout said juncture and saidbody portion being not greatly smaller than said maximum diameter ofsaid adapter;

said body portion, said juncture and said adapter being constructed asan integral unit of a suitable synthetic polymeric material.

1. A unitary disposable endotracheal tube for insertion through the mouth or nose of a patient into the trachea during a surgical operation or the like, comprising: a gently curved body portion having a substantially constant outside diameter of a size such that said portion is adapted to fit in the trachea of the patient; an adapter portion at the end of said tube opposite said body portion, said adapter being suitable for atTaching said tube to surgical equipment, and said adapter having a maximum inside diameter approximately equal to said outer diameter of said body portion; a juncture portion joining said body portion with said adapter portion, said juncture portion being of a length greater than said adapter portion but less than said body portion, and said juncture portion gently curving in such a manner that the end of said juncture portion adjacent said body portion is axially aligned therewith while the end of said juncture portion adjacent said adapter is axially aligned with said adapter; a lumen of generally uniform diameter extending throughout said juncture and body portions of said tube, opening through a gently curved region of nonturbulent flow into said adapter at one end, and through a beveled opening in said body portion at the end of said tube opposite said adapter, the diameter of said lumen throughout said juncture and said body portion being not greatly smaller than said maximum diameter of said adapter; said body portion, said juncture and said adapter being constructed as an integral unit of a suitable synthetic polymeric material.
 2. A unitary disposable endotracheal tube for insertion through the mouth or nose of a patient into the trachea during a surgical operation of the like, comprising: a gently curved body portion having a substantially constant outside diameter of a size such that said portion is adapted to fit in the trachea of the patient; an adapter portion at the end of said tube opposite said body portion, said adapter being suitable for attaching said tube to surgical equipment, and said adapter having a maximum inside diameter approximately equal to said diameter of said body portion; a juncture portion joining said body portion with said adapter portion, said juncture portion being of a length greater than said adapter portion but less than said body portion; said juncture portion being corrugated to provide a flexible connection at any desired angle between said adapter and said body portion, the outside diameter of said corrugated portion being not significantly greater than the outside diameter of either said body portion or said adapter, a lumen of generally uniform diameter extending throughout said juncture and body portions of said tube, opening through a gently curved region of nonturbulent flow into said adapter at one end, and through a beveled opening in said body portion at the end of said tube opposite said adapter, the diameter of said lumen throughout said juncture and said body portion being not greatly smaller than said maximum diameter of said adapter; said body portion, said juncture and said adapter being constructed as an integral unit of a suitable synthetic polymeric material. 